Are old patients not fit for clinical trials, or do clinical trials not fit to old patients? A survey in 35 pharmaceutical companies

Clinical data and evidence-based guidelines for prescriptions for older patients are rare, and older patients are often excluded from clinical trials. The aim of this study was to use a questionnaire to assess the interest of pharmaceutical companies in including patients over 70 years of age in relevant pharmaceutical clinical trials. Additionally, the use of geriatric assessment tools was assessed. Overall, 35 international pharmaceutical companies were selected to report all studies performed over a 10-year period (1999 to 2009), and a total of 26 studies reported by eight companies were evaluated. In 19.2% of the studies, older patients were included but not analyzed separately. In 53.9% of the studies, age was either considered as a covariate or analyzed in a subgroup analysis. Seven studies included only patients aged 70 years and older. However, geriatric assessment tools were only utilized in four studies. Older patients were sufficiently included and analyzed in only a minority of company-initiated pharmaceutical studies. Given current demographic changes, there is an urgent need to address this situation.